Heat Biologics Inc., a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, has unveiled enhanced allogeneic cell therapy manufacturing capabilities through its Scorpion Biological Services subsidiary.
 
Jeff Wolf, CEO of Heat, commented, “We are excited to rollout our new 3-D allogeneic cell manufacturing capabilities to replace our current 2-D HS-110 manufacturing. This new process is designed to increase yield, improve operating efficiency, as well as provide both a rapid and scalable solution to support Phase 3 trials and commercialization.”
 
The company plans to implement these processes for the manufacturing of its own therapies, including HS-110, as well as provide these services to other biopharma companies on a fee-for-service basis through its Scorpion subsidiary.
 
“One of the greatest challenges to broad adoption of cell therapies has been the time and cost of production. We believe these capabilities will help position Scorpion as a leading contract development and manufacturing organization (CDMO), as we advance our mission to become a fully-integrated biopharmaceutical company,” Wolf said.
 
The company is incorporating these manufacturing changes into its clinical and commercial plans for HS-110 and plans to discuss these changes with the FDA during its Type C meeting scheduled for next quarter.
 
Wolf continued, “We have received positive industry feedback on our new 3-D process, as well as the clinical results of our Phase 2 trial of HS-110, and plan to accelerate discussions with potential partners following our FDA interaction. We then plan to resubmit a Type B meeting request, including clinical setting and selection of the checkpoint inhibitor to be used in combination with HS-110, in collaboration with a potential partner.”